FDA Approves Elura (capromorelin oral solution) for Managing Weight Loss in Cats with Chronic Kidney Disease
October 19, 2020
The U.S. Food and Drug Administration has approved Elura (capromorelin oral solution), the second drug approved for management of weight loss in cats and the first drug approved specifically for the management of weight loss in cats with chronic kidney disease.
Cats with chronic kidney disease (CKD) may begin to lose weight prior to diagnosis and typically continue to lose weight as the disease progresses. This weight loss can worsen cats’ prognosis and shorten their lifespan.
Capromorelin is a ghrelin receptor agonist known to increase appetite and weight gain and is approved as ENTYCE for appetite stimulation in dogs. Elura is the second product that the FDA has approved for the management of unintended weight loss in cats.
The sponsor of Elura conducted a 56-day field effectiveness study comparing Elura oral solution to a control group in client-owned cats, which received the oral solution without the drug. All cats had documented, unintended weight loss and a history of CKD. Although enrolled cats were in stable clinical condition, most had a variety of other conditions in addition to CKD, including hyperthyroidism and hypertension, which were managed with medications. At the end of the study, cats that had been given Elura had gained weight, while cats in the control group had lost weight.
The sponsor conducted a 6-month safety study in healthy domestic shorthair cats. The cats were dosed with water or Elura at 1, 3, or 5 times the labeled dose of 2 mg/kg once daily for six months. Elura caused weight gain in all treatment groups compared to the cats receiving water, and the groups that were given 3 and 5 times the labeled dose of Elura consumed more of the food offered to them than cats in the other groups.
The most common adverse reactions observed in both studies were vomiting and hypersalivation, which were both seen more frequently in male cats.
The sponsor also conducted a 32-day laboratory study in eight healthy juvenile male neutered cats to provide information on the drug’s effects on the cardiovascular system and blood glucose levels. Elura administration resulted in transient decreases in both heart rate and direct blood pressure, and transient increases in blood glucose level.
Elura is supplied in 15 mL bottles with an oral dosing syringe. Elura is available by prescription only because professional expertise is required to diagnose and manage CKD in cats and monitor for any adverse reactions.
Elura is sponsored by Elanco US, Inc., based in Greenfield, Indiana.
For more information:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.